FDA Approves Indivior Opioid-use Disorder Treatment

Indivior PLC (INDV.L) said that the U.S. Food and Drug Administration has approved SUBLOCADE (buprenorphine extended- release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder or OUD in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days.

SUBLOCADE is intended to be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support. SUBLOCADE is expected to be available to patients in the U.S. in the first-quarter of 2018.

SUBLOCADE will be distributed through a restricted distribution system, which is intended to prevent the direct distribution to a patient. This is because of risk of serious harm or death that could result from intravenous self-administration.